Important Safety Information - Compounded Testosterone Cypionate

What is this?

This Important Safety Information summarizes the most important warnings and precautions for compounded testosterone cypionate, a compounded injectable prescription medication your provider has prescribed to treat testosterone deficiency (hypogonadism). It does not contain all possible information. You will also receive a medication guide or patient drug information sheet with your medication when it arrives from the pharmacy. Read all of the information that comes with your prescription before using your medication and at each refill, and always follow your prescription label and your provider’s instructions.

Compounded testosterone cypionate is compounded by licensed pharmacists using the active pharmaceutical ingredient testosterone cypionate. Unless otherwise indicated, the safety information below is based on the known safety profile of this active ingredient as used in the compounded medication.

Like all compounded medications, compounded testosterone cypionate is not FDA approved. This means the safety, effectiveness, and quality of this medication have not been verified by the FDA, as the FDA does not verify the safety, effectiveness, and quality of any compounded drugs.

Controlled Substance Information

Testosterone cypionate is a Schedule III (CIII) controlled substance because it contains testosterone, which can be a target for misuse. Keep this medication in a safe place and never give it to anyone else, even if they have similar symptoms—sharing or selling it is against the law and can cause serious harm.

Misuse of testosterone, particularly at higher-than-prescribed doses or combined with other anabolic-androgenic steroids, can cause serious heart and mental health effects. Your healthcare provider may screen you for signs of misuse before and during treatment.

Most Serious Warnings

Testosterone cypionate can cause:

  • Increased blood pressure, which can raise cardiovascular risk (including heart attack and stroke) over time. Your provider will monitor your blood pressure, and testosterone cypionate is not recommended if you have high blood pressure that isn’t controlled. A large clinical trial (TRAVERSE) of a different testosterone formulation (topical gel) found no increase in these events in men treated for low testosterone compared with placebo, but your provider will still keep an eye on your heart health.

  • Polycythemia (a significant rise in red blood cell count; hematocrit ≥54%), which increases the risk of blood clots, stroke, and heart attack.

  • Blood clots in the legs or lungs (deep vein thrombosis, pulmonary embolism).

  • Worsening of sleep apnea, particularly in patients with obesity or chronic lung conditions.

  • Prostate growth or worsening of a pre-existing prostate condition. Testosterone can also stimulate hormone-sensitive cancers such as prostate or breast cancer.

Seek medical help right away if you develop symptoms of any of these.

Who Should NOT Use Testosterone Cypionate

Do not use testosterone cypionate if you:

  • Have known or suspected prostate or breast cancer

  • Have a known hypersensitivity to testosterone cypionate, benzyl alcohol, benzyl benzoate, or MCT oil

  • Have serious heart, liver, or kidney disease (such as unstable angina, a very recent heart attack, severe congestive heart failure, or active liver disease with persistently abnormal liver tests)

  • Have polycythemia vera or a hematocrit ≥54%

  • Have a condition that makes your blood clot too easily, such as Factor V Leiden, protein C or S deficiency, antithrombin deficiency, a prothrombin gene mutation, sickle cell anemia, antiphospholipid syndrome, or paroxysmal nocturnal hemoglobinuria

  • Have an active, untreated pituitary or adrenal condition that hasn't been evaluated by a specialist

  • Are using anabolic steroids or have used them within the past 6 months

Before Using Testosterone Cypionate, Tell Your Healthcare Provider if You:

  • Have a history of heart disease, stroke, or cardiovascular procedures

  • Have high blood pressure or are taking blood pressure medications

  • Have been diagnosed with sleep apnea or have been told you snore heavily

  • Have diabetes or take insulin or blood sugar medications

  • Have prostate conditions, including an elevated PSA or BPH (enlarged prostate)

  • Have blood clots or a personal or family history of blood clots

  • Have a condition that can raise your red blood cell count, such as hemochromatosis

  • Have liver or kidney conditions

  • Have a history of cancer, especially hormone-sensitive cancers such as prostate or breast cancer

  • Have abnormal hematocrit or red blood cell lab results

  • Have a bleeding disorder or difficulty with injections

  • Are taking anticoagulants (blood thinners) such as warfarin

  • Are taking corticosteroids

  • Are taking any medications that affect hormone levels (e.g., other androgens, clomiphene, hCG, or aromatase inhibitors)

  • Are taking medications that can raise blood pressure, such as some cold or pain medicines

  • May want to have children in the future (testosterone suppresses sperm production — see “Pregnancy and Fertility”)

Safe Injection and Handling

  • Always use a new, sterile needle and syringe for each injection; never reuse or share injection supplies

  • Clean the rubber stopper with an alcohol swab before each withdrawal

  • This is a multi-dose vial; discard it 28 days after first use or on the beyond-use date on your label, whichever comes sooner, even if medication remains

  • Rotate injection sites and follow the injection technique provided by your Care Team

  • Inspect the solution before each use; when cold the oil may look thick or slightly cloudy and should clear at room temperature. Do not use it if it stays discolored or cloudy or contains particles that do not dissolve

  • Dispose of used needles, syringes, and empty or expired vials in an approved sharps container

Possible Side Effects

Common:

  • Injection-site pain, redness, swelling, or bruising

  • Increased blood pressure

  • Increased hematocrit (red blood cell count)

  • Acne or oily skin

  • Increased PSA

  • Headache

  • Mood changes or irritability

  • Fluid retention or swelling

  • Breast tenderness or enlargement (gynecomastia)

  • Fertility changes, including smaller testicles and lower sperm count

  • Fatigue

  • Increased or decreased libido

Serious (seek medical care immediately):

  • Signs of blood clots (leg swelling or pain, chest pain, shortness of breath, sudden vision changes, difficulty speaking)

  • Signs of stroke (sudden weakness or numbness, severe headache, confusion, vision or speech changes)

  • Difficulty breathing during sleep or worsening snoring

  • A severe or sudden increase in blood pressure

  • Signs of liver problems (yellowing of the skin or eyes, dark urine, abdominal pain) — these are mainly linked to older oral steroids, not injectable testosterone cypionate, and are very rare with this medication

  • Sudden visual changes or vision loss

  • New or worsening urinary symptoms (difficulty urinating, weak urine stream)

  • Signs of an injection-site infection (increasing pain, warmth, redness, swelling, or pus)

  • Signs of a serious allergic reaction (hives, swelling of the face/lips/throat, difficulty breathing)

While Using Testosterone Cypionate

Tell your healthcare provider right away if you:

  • Start any new medication, especially blood thinners, insulin, corticosteroids, 5-alpha reductase inhibitors (finasteride or dutasteride, which can also lower your PSA reading), or other hormone-modifying medications

  • Are diagnosed with a new medical condition, including prostate or cardiovascular conditions

  • Experience changes in mood, sleep, or energy that concern you

  • Develop signs of a blood clot (leg swelling or pain, chest pain, shortness of breath), stroke (sudden weakness, numbness, confusion, or vision or speech changes), liver problems (yellowing of the skin or eyes, dark urine, belly pain), a serious allergic reaction, or new or worsening urinary symptoms

  • Miss doses consistently or notice reduced effectiveness over time

Pregnancy and Fertility

  • Not for use in women. Women who are or may become pregnant should not handle this medication; testosterone can harm an unborn baby.

  • Testosterone suppresses sperm production and may reduce fertility during treatment. For many men this is reversible after stopping, but recovery is not guaranteed.

  • If you are trying to conceive, discuss this with your healthcare provider before starting. This medication is not appropriate for patients whose primary goal is to preserve or restore fertility.

These are not all the side effects of testosterone cypionate. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Stop using your medication and seek urgent medical care if serious side effects occur.

Overdose

In case of overdose, seek medical attention immediately or contact Poison Control at 1-800-222-1222.

Missed Dose

If you miss an injection, take it as soon as you remember, then return to your normal schedule. Testosterone cypionate is long-acting, so a short delay is not a problem. Do not inject a double dose to make up for a missed one. If you’ve missed several doses or aren’t sure what to do, reach out to your Care Team.

Storage

  • Store at room temperature between 68°F and 77°F (20°C to 25°C). Protect from light and keep in a dry place; do not freeze.

  • This is a multi-dose vial — discard 28 days after first use (or on the beyond-use date on your label), even if medication remains

  • Keep medication, needles, and syringes out of the reach of children

Medication and Sharps Disposal

Place used needles, syringes, and empty or expired vials in an FDA-cleared sharps disposal container (or a puncture-resistant, tightly lidded heavy-duty plastic container). Do not place loose needles in household trash, and do not flush medication or pour it down a drain. For unused or expired medication, because testosterone is a controlled substance, use a DEA drug take-back site. See FDA – Safely Using Sharps and FDA – Disposal of Unused Medicines.

Telemedicine Disclosure: This prescription was issued via telemedicine. If you experience any concerning symptoms, contact your prescribing clinician or seek emergency care.

Disclaimer: This summary does not include all information about compounded testosterone cypionate injection. For more details, speak with your healthcare provider or pharmacist. This information is intended to support, not replace, discussions with your healthcare provider.